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| Name | Class |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Cox's Bazar 250 Bed District Sadar Hospital | UNKNOWN |
| Chattogram General Hospital | OTHER_GOV |
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This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Remdesivir + Tocilizumab treatment group | Experimental | Drug: Remdesivir Injectable solution Tocilizumab Injectable solution A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization. Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart. |
|
| Group B: Control group | No Intervention | Treatment as given without Remdesivir and Tocilizumab. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Remdesivir 100 IV Infusion as a lyophilized powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Improvement (TTCI) | Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of \ | Following randomization 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ICU Stay | Duration of ICU Stay in Days | Following randomization 30 days. |
| Mortality Rate | Mortality Rate on Days during hospitalization |
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Inclusion Criteria:
Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Akter Kamal, MD, PhD | M Abdur Rahim Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chattogram General Hospital | Chittagong | 4000 | Bangladesh | |||
| Cox's Bazar 250 Bed District Sadar Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35450050 | Derived | Mohiuddin Chowdhury ATM, Kamal A, Abbas KU, Talukder S, Karim MR, Ali MA, Nuruzzaman M, Li Y, He S. Efficacy and Outcome of Remdesivir and Tocilizumab Combination Against Dexamethasone for the Treatment of Severe COVID-19: A Randomized Controlled Trial. Front Pharmacol. 2022 Apr 5;13:690726. doi: 10.3389/fphar.2022.690726. eCollection 2022. |
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| Tocilizumab | Drug | Actemra IV Infusion |
|
|
| Following randomization 30 days. |
| Time to Recovery | Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed | Following randomization 30 days. |
| Hospital stay | Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or \ | Following randomization 30 days. |
| Rate of daily Supplemental Oxygen Use | Rate of daily Supplemental Oxygen Use by the patient | Following randomization 30 days. |
| Time to Clinical Failure | Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation or Withdrawal (whichever occurs first) | Following randomization 30 days. |
| Cox’s Bāzār |
| Bangladesh |
| M. Abdur Rahim Medical College Hospital | Dinajpur | 5200 | Bangladesh |
| M. Abdur Rahim Medical College Hospital | Dinajpur | Bangladesh |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
| C502936 | tocilizumab |
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